SelectHealth Advantage 2018 Prior Authorization Criteria
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- Brian Stafford
- 6 years ago
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1 ACROMEGALY SOMATULINE DEPOT, SOMAVERT * Acromegaly 1. Pt has had surgical resection of the pituitary gland OR is not a candidate for surgery/radiation therapy, 2. Patient has tried at least ONE of the following: a. Bromocriptine, b. Cabergoline, c. Octreotide Endocrinologist, Oncologist, or consult 2
2 ACTEMRA ACTEMRA * Giant Cell Arteritis (GCA) * Juvenile Idiopathic Arthritis (JIA) * Rheumatoid Arthritis (RA) 1. For rheumatoid arthritis dx: a. Pt has previous trial on at least ONE of the following: i. Enbrel, ii. Humira, 2. For juvenile rheumatoid arthritis dx: a. Pt has failed on at least ONE of the following: i. methotrexate, ii. leflunomide, iii. hydroxychloroquine, iv. sulfasalazine, v. injectable gold, vi. oral gold, vii. azathioprine, viii. penicillamine, ix. cyclosporine, b. Pt has previous trial on at least ONE of the following: i. Enbrel, ii. Humira Rheumatologist 3
3 ACTHAR H.P. ACTHAR * Ankylosing Spondylitis * Dermatomyositis * Erythema Multiforme * Infantile Spasms * Multiple Sclerosis (MS) * Nephrotic Syndrome * Rheumatoid Arthritis (RA) * Sarcoidosis * Stevens-Johnson Syndrome * Systemic Lupus Erythematosus (SLE) 1. For Infantile Spasms: a. Dx is confirmed by EEG, b. Pt has tried at least ONE of the following: i. Prednisone, ii. Prednisolone, iii. Hydrocortisone, iv. Dexamethasone, c. Pt has tried at least ONE of the following: i. Vigabatrin, ii. Cosyntropin, 2. For MS: a. Pt has failed at least TWO courses of treatment with Solu-Medrol for two different multiple sclerosis exacerbations, 3. For Nephrotic Syndrome: a. Pt has tried at least TWO corticosteroids, b. Pt has tried at least ONE of the following: i. Cyclophosphamide, ii. Cyclosporine, 4. For Rheumatic Disorders: 4
4 a. Pt has tried at least ONE oral corticosteroid, b. Pt has tried at least ONE oral DMARD, 5. For Dermatologic Disorders: a. Pt has failed therapy with methylprednisolone Infantile Spasms: 24 months old or younger 1. Infantile Spasms: Neurologist, 2. MS: Neurologist, 3. Nephrotic Syndrome: Nephrologist, 4. Rheumatic Disorders: Rheumatologist, 5. Dermatologic Disorders: Dermatologist 1 mo 5
5 ACTIMMUNE ACTIMMUNE * Chronic Granulomatous Disease 1. Hypersensitivity to Actimmune or E. coli derived products 6
6 ADEMPAS ADEMPAS * Chronic Thromboembolic Pulmonary Hypertension (CTEPH) * Pulmonary Arterial Hypertension (PAH) 1. PAH: a. Pt has previous failure on sildenafil, 2. CTPH: a. Pt has failed endarterectomy OR b. Pt considered inoperable for pulmonary endarterectomy AND c. Pt has previous trial on full anticoagulation for at least 90 days 18 years old or older Specialist in pulmonary hypertension 7
7 ALECENSA ALECENSA, ALUNBRIG * Non-Small Cell Lung Cancer (NSCLC) 1. Pt has sensitizing EGFR mutations, 2. Pt has previous failure on ANY of the following: a. Erlotinib, 2. Gefitinib, 3. Afatinib 1. Pt has previous failure on Xalkori Oncologist 8
8 ALIMTA ALIMTA * Mesothelioma * Non-Squamous Non-Small Cell Lung Cancer (NSCLC) 1. For mesothelioma: a. Unresectable disease OR not candidate for surgery, b. Used in combination with cisplatin or carboplatin, 2. For NSCLC a. Initial: used in combo with cisplatin or carboplatin, b. Maintenance tx: Used after failure of four cycles of platinum-based first-line chemotherapy, c. After prior chemotherapy: Alimta used as single chemotherapeutic agent 9
9 ALIQOPA ALIQOPA * Follicular Lymphoma 1. Pt has failed at least TWO prior therapies including rituximab and an alkylating agent Oncologist or Hematologist 10
10 AMPHOB AMBISOME, AMPHOTERICIN B * Aspergillosis * Candidiasis * Coccidioidomycosis * Cryptococcosis (Torulosis) * Histoplasmosis * Infection caused by related susceptible species of Conidiobolus, Basidiobolos, and Sporotrichosis * North American Blastomycosis 1. For use of brand Ambisome: a. Pt must have previous failure or contraindication to generic Amphotericin B, 2. If using for empiric therapy: a. Patient must be febrile AND neutropenic BvsD determination 11
11 AMPYRA AMPYRA * Multiple Sclerosis (MS) 1. Pt confined to wheelchair, 2. Hx of seizures, 3. Moderate to severe renal impairment (CrCl is less than 50 ml/min) 1. Initial: a. Currently taking at least one other MS drug, b. Documented 25 foot walk time, 2. Reauth: a. Currently taking at least one other MS drug, b. Improvement in 25 foot walk time Neurologist Initial: 3 mo, Reauth: 12
12 ANDROGENS ANDRODERM, AXIRON, TESTOSTERONE * 1. Two separate testosterone levels drawn on different dates where the total testosterone level is below 300 ng/dl, 2. Pt experiences at least ONE of the following: a. malaise, b. fatigue, c. lethargy, d. muscle loss, e. depression, f. decreased libido, 3. Previous trial on Androgel If request NOT for Androgel: Previous trial of Androgel 13
13 APO B JUXTAPID, KYNAMRO * Low-Density Lipoprotein (LDL) level higher than 500mg/dL, Untreated, Unfasting Pt has none of the following health conditions or health concerns: a. History of significant hepatic disease, b. Alcohol abuse, c. History of significant renal disease for Kynamro 1. Pt has untreated, fasting LDL cholesterol greater than 500 mg/dl AND triglycerides less than 300 mg/dl, 2. Pt meets a OR b AND c of the following: a. Pt has documented mutations in both alleles of the LDL receptor or of other genes known to affect LDL receptor function, b. Both of pt's parents have a hx of untreated total cholesterol of greater than 250 mg/dl, c. Pt has xanthomas present before age 10, 3. Pt has failed or is currently taking at least ONE of the following: a. Atorvastatin, b. Rosuvastatin, c. Simvastatin, 4. Pt has previous trial of Repatha OR Praluent Cardiologist or Endrocrinologist 1. Initial: 6 mo, 2. Reauthorization: 12 mo 14
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15 APOKYN APOKYN * Parkinson's Disease 1. Pt suffering from end of dose wearing off episodes, 2. Apokyn initiated with a concomitant antiemetic (not a 5HT3) Neurologist 16
16 ARCALYST ARCALYST * Cryopyrin-Associated Periodic Syndrome (CAPS) 1. Combination use with a TNF-inhibitor 17
17 AVASTIN AVASTIN * Cervical Cancer * Colorectal Cancer * Fallopian Tube Cancer * Glioblastoma Multiforme * Non-Squamous Non-Small Cell Lung Cancer (NSCLC) * Ovarian Cancer * Peritoneal Cancer * Renal Cell Carcinoma (RCC) 1. For metastatic, colon, or rectal cancer dx: a. Used in combination with 5-flurouracil OR capecitabine, 2. For NSCLC dx: a. Used in combination with carboplatin/paclitaxel OR erlotinib, 3. For glioblastoma multiforme: a. Previous failure on temozolomide, 4. For RCC dx: a. Used in combination with interferon alpha, 5. For cervical cancer dx: a. Used in combination with paclitaxel/cisplatin OR paclitaxel/topotecan, 6. For ovarian/fallopian tube/periotoneal cancer dx (either a, b, or c): a. Used in combination with ONE of the following: i. paclitaxel, ii. pegylated liposomal doxorubicin, or iii. weekly topotecan, OR b. Used in combination with topotecan given every 3 weeks, OR c. Used in combination with carboplatin and paclitaxel or in combination with carboplatin and gemcitabine 18
18 Oncologist or Hematologist 19
19 BANZEL BANZEL * Lennox-Gastaut Syndrome 1. Pt has inadequate seizure control despite treatment with at least ONE anti-epileptic drug Neurologist 20
20 BAVENCIO BAVENCIO * Merkel Cell Carcinoma (MCC) * Urothelial Carcinoma 1. Pt has previously received treatment with an anti-pd-1, anti-pd-l-!, or anti-ctla-4 therapy, 2. Pt has an autoimmune disease or medical condition that requires treatment with corticosteroids or other systemic immunosuppressive treatment, 3. Pt has CNS metastases, 4. Pt has known active infection with HIV, hepatitis B, or hepatitis C or a history of an organ transplant or allogeneic stem cell transplant 1. For all dx: a. Pt's ECOG performance score is 2 or less, 2. For urothelial carcinoma dx: a. PT has experienced disease progression following platinum-containing chemotherapy 12 years old or older Oncologist or Hematologist 21
21 BELEODAQ BELEODAQ * Peripheral T-Cell Lymphoma (PTCL) Oncologist 22
22 BENLYSTA BENLYSTA * Systemic Lupus Erythematosus (SLE) Use in severe active lupus nephritis or severe active CNS lupus 1. Pt is currently autoantibody positive, 2. Pt has current active disease, 3. Pt has previous treatment with at least TWO of the following: a. Corticosteroids, b. Antimalarials, c. Immunosuppressives, 4. Pt will continue to receive concomitant standard treatment with at least ONE of the following: a. Corticosteroids, b. Antimalarials, c. Immunosuppressives Rheumatologist 23
23 BETASERON BETASERON * Multiple Sclerosis (MS) Previous trial on at least TWO of the following: 1. Avonex, 2. Copaxone, 3. Extavia, 4. Gilenya, 5. Plegridy, 6. Tecfidera Neurologist 24
24 BOSULIF BOSULIF * Chronic Myelogenous Leukemia (CML) 1. Pt's CML is in chronic phase, accelerated phase, or blast phase, 2. Pt has previous failure or intolerance to Gleevec (imatinib) Oncologist 25
25 CABOMETYX CABOMETYX * Renal Cell Carcinoma (RCC) 1. Pt received prior anti-angiogenic therapy Oncologist 26
26 CALQUENCE CALQUENCE * Mantle Cell Lymphoma (MCL) 1. Pt has been treated with at least one prior therapy Oncologist or Hematologist 27
27 CANCIDAS CANCIDAS, CASPOFUNGIN ACETATE * Aspergillosis * Candidemia * Esophageal Candidiasis 1. For invasive aspergillosis: a. Pt has failure on at least ONE other systemic antifungal, 2. If using for empiric therapy: a. Patient must be febrile AND neutropenic BvsD determination 28
28 CAPASTAT CAPASTAT SULFATE * Tuberculosis Pt has previous failure on at least ONE of the following: 1. Isoniazid, 2. Rifampin, 3. Ethambutol, 4. Pyrazinamide Infectious Disease Specialist 10 Months BvsD determination 29
29 CAPRELSA CAPRELSA * Thyroid Cancer Oncologist, Hematologist, or Endocrinologist 30
30 CARBAGLU CARBAGLU * Hyperammonemia due to N-Acetylglutamate Synthase Deficiency Specialist in Medical Genetics or Metabolic Specialist 6 Months 31
31 CERDELGA CERDELGA * Gaucher Disease 1. Pt was diagnosed by a Clinical Biomedical Geneticist, 2. Pt is unable to use intravenous enzyme replacement, 3. The CYP2D6 genotype has been determined 32
32 CESAMET CESAMET * Cancer-Associated Anorexia * HIV-Associated Wasting Syndrome 1. Pt has previous trial of olanzapine, 2. Pt has previous trial of dronabinol 33
33 CHOLBAM CHOLBAM * Bile Acid Synthesis Disorders * Peroxisomal Disorders (PDs) * Zellweger Spectrum Disorder 1. Initial: a. Pt has abnormal results from a urinary bile acids analysis by FAB-MS and neurologic exam, 2. Reauth: a. After at least 3 mo of therapy ALT and AST values have been reduced to less than 50 U/L OR baseline reduced by 80%, b. After at least 3 mo of therapy total bilirubin values have been reduced to less than or equal to 1 mg/dl, c. Pt's body weight has increased by 10% or is stable at the greater than 50th percentile OR liver biopsy shows no evidence of cholestasis since initiation of therapy Gastroenterologist Initial: 6 months, Reauth: 12 months 34
34 CHORIONIC GONADOTROPIN CHORIONIC GONADOTROPIN * Hypogonadism * Percocious Puberty Fertillity Use 1. For hypogonadism dx: a. Pt previously failed on testosterone replacement therapy 35
35 CIMZIA CIMZIA * Ankylosing Spondylitis * Psoriatic Arthritis (PsA) * Rheumatoid Arthritis (RA) Combination therapy with TNF antagonist 1. RA dx: Pt has failed on at least ONE of the following: a. methotrexate, b. leflunomide, c. hydroxychloroquine, d. sulfasalazine, e. injectable gold, f. oral gold, g. azathioprine, h. penicillamine, i. cyclosporine, 2. All dx: Pt has failed at least ONE of the following: a. Enbrel, b. Humira Rheumatologist or Gastroenterologist 36
36 CINRYZE CINRYZE * Angioedema 1. Dx is verified by low C1-INH and/or low C1-INH functional levels on two separate occasions (for Type I or Type II) OR pt is diagnosed with Type III Hereditary Angiodema, 2. Therapy is required as follows: a. Pt has history of 2 or more HAE attacks per month, AND b. Pt has tried or has contraindication to a 30 day trial of attenuated androgen therapy OR c. Pt is scheduled to undergo a major medical procedure that requires propylaxis, 3. Reauth: a. Pt has had a significant decrease in the frequency of attacks per month OR had a significant decrease in the severity or duration of attacks Allergist or Immunologist 6 Months 37
37 COMETRIQ COMETRIQ * Metastatic Medullary Thyroid Carcinoma Diagnosis of indolent medullary thyroid cancer Oncologist 38
38 COSENTYX COSENTYX, COSENTYX SENSOREADY PEN * Ankylosing Spondylitis * Plaque Psoriasis * Psoriatic Arthritis (PsA) 1. For Plaque psoriasis dx: a. Plaque psoriasis involves 10% or more of the body surface area, b. If less than 10% of body surface area there is scalp, palmer, foot, or groin involvement causing significant disability, c. Pt has failed therapy of at least 12 weeks with at least ONE of the following: i. methotrexate, ii. cyclosporine, iii. acitretin, d. Pt has failed treatment with Enbrel OR Humira, 2. Ankylosing spondylitis dx: a. Pt has failed treatment with Enbrel OR Humira, 3. Psoriatic arthritis dx: a. Pt has previous failure of at least ONE of the following: i. Methotrexate, ii. Leflunomide, iii. Hydroxychloroquine, iv. Sulfasalazine, v. Injectable Gold, vi. Oral Gold, vii. Azathioprine, viii. Penicillamine, ix. Cycloprine, b. Pt has failed treatment with Enbrel OR Humira 18 years old or older Dermatologist or Rheumatologist 39
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40 CRESEMBA CRESEMBA * Aspergillosis * Mucormycosis Cresemba is initiated incident to a hospitalization Infectious Disease Specialist 6 Months 41
41 CUBICIN DAPTOMYCIN * Blood Stream Infection * Skin and Skin Structure Infection 1. For complicated bacterial skin and skin structure infections: Pt has had a positive culture within the past month for ANY of the following (mark all that apply): a. Staphylococcus aureus (MSSA or MRSA), b. Streptococcus pyogenes, c. Streptococcus agalactia, d. Streptococcus dysgalactiae subspecies equisimilis, e. Enterococcus faecalis (vancomycin susceptible strains only), 2. For blood stream infections: Pt has had a positive culture within the past month for Staphylococcus aureus (MSSA or MRSA) Infectious Disease Specialist 2 Months BvsD determination 42
42 CYRAMZA CYRAMZA * Colorectal Cancer * Gastric Cancer * Gastro-Esophageal Junction (GEJ) Adenocarcinoma * Non-Small Cell Lung Cancer (NSCLC) 1. Gastric cancer dx: a. Pt has previous trial on either fluoropyrimidine OR platinum containing chemotherapy, b. Cyramza is used as monotherapy OR combination therapy with paclitaxel, 2. Metastatic colorectal cancer dx: a. Pt has previous trail on bevacizumab, oxaliplatin and a fluoropyrimidine, b. Cyramza is used in combination with irinotecan, folinic acid, and 5-FU, 3. Metastatic NSCLC dx: a. Pt has previous trial on platinum-based chemotherapy, b. Cyramza is used in combination with docetaxel, c. If patient has EGFR OR ALK tumor aberrations pt has had disease progression on a FDA-approved therapy for these aberrations Oncologist 43
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44 CYSTARAN CYSTARAN * Cystinosis 1. Initial: a. Pt has corneal cysteine accumulation that has been confirmed by slit-lamp photography, 2. Reauth: a. Pt had a reduction of 1 or more units in the Corneal Cystine Crystal Score (CCCS) after 6 months of treatment with Cystaran. Corneal Specialist, Endocrinologist, or Ophthalmologist 6 Months 45
45 CYSTIC FIBROSIS BETHKIS, CAYSTON, TOBI PODHALER, TOBRAMYCIN * Cystic Fibrosis 1. Pt has had at least ONE positive culture for Pseudomonas aeruginosa Pulmonologist or Infectious Disease Specialist BvsD determination 46
46 DAKLINZA * Hepatitis C Virus (HCV), Genotype 3 Previous treatment with Daklinza 1. Daklinza used in combination with Sovaldi Gastroenterologist, Infectious Disease Specialist, Transplant Specialist, or Hepatologist Maximum 24 Weeks 47
47 DALVANCE BAXDELA, DALVANCE, ORBACTIV * Skin and Skin Structure Infection 1. Chart notes and bacterial susceptibility reports have been submitted showing need for IV medication Infectious Disease Specialist 14 Days BvsD determination 48
48 DARZALEX DARZALEX * Multiple Myeloma 1. Darzalex monotherapy: a. Pt has failed at least THREE prior therapies including at least ONE proteasome inhibitor and at least ONE immunomodulatory agent, OR b. Pt is double-refractory to BOTH a proteasome inhibitor AND an immunomodulatory agent, 2. Darzalex combination therapy: a. Pt is refractory to or has relapsed after at least ONE prior therapy for the treatment of multiple myeloma Oncologist or Hematologist 49
49 DEPEN DEPEN TITRATABS * Cystinuria * Wilson Disease 1. For cystinuria dx: a. Pt has failure of conservative treatment measures including the following: i. High fluid intake, ii. Sodium and protein restriction, iii. Urinary alkalization with potassium citrate, potassium bicarbonate, or acetazolamide, b. Pt has previous failure with Thiola. 50
50 DIFICID DIFICID * Clostridium Difficile (C.Diff) associated Diarrhea 1. Pt has had a positive C. difficile toxin assay within the past month, 2. Pt has tried as least TWO of the following treatments: a. Metronidazole for days, b. Vancomycin for days, c. Vancomycin extended taper, d. Rifaximin for 14 days. Gastroenterologist or Infectious Disease Specialist 51
51 DRONABINOL DRONABINOL * Cancer-Associated Anorexia * HIV-Associated Wasting Syndrome 1. For HIV-associated wasting syndrome OR cancer-associated anorexia dx: a. Pt has previous trial on megestrol, 2. For CINV dx: a. Pt has previous trial on olanzapine 52
52 DUPIXENT DUPIXENT * Atopic Dermatitis 1. Atopic dermatitis involves 10% body surface area or more, 2. Pt has previous trail on tacrolimus 0.1% ointment, 3. Pt has previous trail on at least ONE of the following: a. Cyclosporine, 2. Azathioprine, 3. Methotrexate 18 years old or older Allergist, Dermatologist, or Immunologist 53
53 EMPLICITI EMPLICITI * Multiple Myeloma 1. Empliciti will be used in combination with Revlimid AND dexamethasone, 2. Pt has previous trial on at least ONE previous therapy Oncologist or Hematologist BvsD Determination 54
54 ENBREL ENBREL, ENBREL SURECLICK * Ankylosing Spondylitis * Plaque Psoriasis * Psoriatic Arthritis (PsA) * Rheumatoid Arthritis (RA) 1. RA, JRA, PsA dx: Pt has failed at least three months therapy on at least ONE of the following: a. methotrexate, b. leflunomide, c. hydroxychloroquine, d. sulfasalazine, e. injectable gold, f. oral gold, g. azathioprine, h. penicillamine, i. cyclosporine Rheumatologist, Dermatologist, or Gastroenterologist 55
55 ENDOTHELIN ANTAGONIST LETAIRIS, OPSUMIT, TRACLEER * Pulmonary Arterial Hypertension (PAH) 1. Exclusion of all secondary causes of pulmonary hypertension, 2. Must be dx with PAH with WHO class II, III, or IV Pulmonoligist or Cardiologist 56
56 ENTRESTO ENTRESTO * Chronic Heart Failure (CHF) 1. Pt has reduced left ventricular ejection fraction of 40% or less 57
57 ENZYME REPLACEMENT ALDURAZYME, ELAPRASE, FABRAZYME, KANUMA, LUMIZYME, NAGLAZYME * Fabry Disease * Mucopolysaccharidosis I with the Hurler Form * Mucopolysaccharidosis I with the Hurler-Scheie Form * Mucopolysaccharidosis I with the Scheie Form * Mucopolysaccharidosis II (Hunter Syndrome) * Mucopolysaccharidosis IVA (MPS IVA) * Mucopolysaccharidosis VI (Maroteaux-Lamy Syndrome) * Pompe Disease Pt was diagnosed by a Clinical Biochemical Geneticist 58
58 EPCLUSA EPCLUSA * Hepatitis C Virus (HCV), Genotype 2 * Hepatitis C Virus (HCV), Genotype 3 * Hepatitis C Virus (HCV), Genotype 5 * Hepatitis C Virus (HCV), Genotype 6 1. Chart notes documenting genotype, 2. For genotype 1 or 4: a. Pt has previous failure on Zepatier OR Mavyret Gastroenterologist, Infectious Disease Specialist, or Transplant Specialist 12 Weeks 59
59 ERBITUX ERBITUX * Colorectal Cancer * Squamous Cell Carcinoma of the Head and Neck (SCCHN) 1. For colorectal cancer dx: a. Failure of BOTH irinotecan- and oxaliplatin- based regimens OR intolerant to irinotecan-based chemotherapy, b. Tumor must bear wild-type (non-mutated) K-ras gene, 2. For head and neck cancer dx: a. Used as a single agent in recurrent cancer where platinum-based therapy has failed OR b. Used in combination with radiation therapy for local or regionally advanced cancer, 3. For ALL dx: a. Patient has no previous failure on Vectibix Oncologist 60
60 ERIVEDGE ERIVEDGE, ODOMZO * Basal Cell Carcinoma 1. Pt has recurring lesions after radiation therapy OR radiation therapy is contraindicated or inappropriate, 2. Pt has recurring lesions after surgical excision OR surgery is contraindicated or inappropriate Dermatologist or Oncologist 61
61 ERWINAZE ERWINAZE * Acute Lymphocytic Leukemia (ALL) 1. Erwinaze is used in combination with chemotherapy for treatment, 2. Pt has demonstrated a hypersensitivity to an E. Coli derived asparaginase Oncologist 62
62 FARESTON FARESTON * Metastatic Breast Cancer 1. Pt has congenital or acquired QT prolongation, 2. Pt has uncorrected hypokalemia, 3. Pt has uncorrected hypomagnesemia 1. Pt has previous trial and failure or contraindication to tamoxifen therapy, 2. Pt has previous trial and failure or contraindication to aromatase inhibitor therapy Oncologist 63
63 FARYDAK FARYDAK * Multiple Myeloma 1. Used in combination with bortezomib and dexamethasone, 2. Pt has previous trial on at least TWO regimens including bortezomib and an immunomodulatory agent Oncologist or Hematologist 64
64 FASENRA FASENRA * Asthma 1. Pt has a hx of 2 or more exacerbations requiring the use of oral corticosteroids in the past 12 months, 2. Pt has been compliant for at least 6 months on all of the following: a. High-dose corticosteroid/long-acting inhaled bronchodilator combination b. Tiotropium bromide, 3. Pt peripheral blood eosinophil level is greater than or equal to 150 cells/mcl within the last 6 months OR greater than equal to 300 cells/mcl within the last 12 months Allergist or Pulmonologist 65
65 FENTANYL ABSTRAL, FENTANYL CITRATE ORAL TRA, FENTORA, LAZANDA * Moderate to Severe Pain associated with Cancer Non-cancer pain use 1. Must have documented maintenance therapy with a long-acting opioid, 2. Documented failure with a short-acting opioid for breakthrough pain Oncologist or Pain Specialist 6 Months Previous trial on generic fentanyl citrate 66
66 FIRAZYR FIRAZYR * Angioedema 1. For HAE type I and II and aquired angioedema: a. Dx has been verified by low C1-INH and/or low C1-INH function levels on two separate occasions, 2. For HAE with normal C1-INH: a. Pt has failed a trial with high-dose non-sedating antihistamines such as cetirizine, desloratadine, or levocetirizine for at least 30 days to rule-out idiopathic angioedema Allergist or Immunologist 1. Initial: 3 mo, 2. Reauth: 1 year 67
67 FOLOTYN FOLOTYN * Mycosis Fungoides/Sezary Syndrome * T-Cell Lymphoma 1. Treatment with prior systemic therapy (such as ICE, DHAP, ESHAP, Gemcitabine, or GDP) Oncologist 68
68 FORTEO FORTEO * Osteoporosis 1. Treatment for longer than 2 years 1. For osteoporosis dx: a. Required WHO FRAX has been completed and pt is determined to be high risk with a 10 year hip fracture probability of greater than 10%, b. Pt has been compliant on Reclast and experienced a fragility fracture, c. Pt is intolerant or has a contraindication to bisphosphonate therapy, d. Pt has been compliant on Prolia and failed therapy as evidenced by fragility fracture or a decline in bone mineral density of greater than 10% while on therapy. BvsD 69
69 GATTEX GATTEX * Short Bowel Syndrome 1. Pt has been dependent on parenteral nutrition or intravenous support for at least 12 months, 2. Pt has required parenteral nutrition at least 3 times per week for at least 12 months, 3. Pt has undergone colonoscopy of the entire colon within the past 6 months Gastroenterologist Initial: 6 months, Reauth: 70
70 GAUCHER CEREZYME, ELELYSO, VPRIV * Gaucher Disease 1. Pt was diagnosed by a Clinical Biomedical Geneticist 1. Pt has previous trial on Elelyso 71
71 GILOTRIF GILOTRIF * Non-Small Cell Lung Cancer (NSCLC) 1. Metastatic NSCLC dx: a. The tumor has an epidermal growth factor receptor (EGFR) exon 19 deletion or exon 21 (L858R) substitution mutation, 2. Metastatic Squamous NSCLC dx: a. Progression after platinum-based chemotherapy Oncologist 72
72 GLEOSTINE GLEOSTINE * Brain Cancer * Hodgkin's Lymphoma Oncologist or Hematologist 73
73 GROWTH HORMONE OMNITROPE, SAIZEN, SAIZEN CLICK.EASY * AIDs-Related Wasting * Chronic Renal Insufficiency * Growth Hormone Deficiency (GHD) * Prader-Willi Syndrome * Short Stature Disorder * Small for Gestational Age (SGA) * Turner's Syndrome 1. For Ped GHD: Male at bone age of 16 yo, Female at bone age of 14 yo, 2. Growth velocity is less than 2 cm/yr, 3. Fusion of epiphyses 1. Ped GHD: a. Initial: Meet criteria i, ii, iii, iv, AND either iv(a), or iv(b), or v: i. Ht more than 2 SD below the pop mean OR less than 3rd percentile, ii. Ht velocity less than 4cm/yr OR less than 5th percentile of bone age and gender for at least 6 mo iii. Evidence of other causes of growth failure have been ruled out AND iv. (a) Failure of at least TWO stim tests (peak GH concentration less than 10mcg/L) OR iv. (b) IGF-1 2 SD or more below the mean standardized for bone age AND IGF-BP3 is in the lowest quartile for bone age and gender AND other causes of low IGF have been excluded, OR v. Pt has more than 3 pituitary hormone deficiencies requiring replacement therapy, b. Reauth: Growth velocity of 4cm/year or more, 2. Adult GHD: a. Initial: Pts must meet any of the criteria i-ii: i. Pt has GH deficiency as a result of hypothalamic or pituitary disease or is dxed with acquired GH deficiency 74
74 (1) Secondary to any of the following: (a) Pituitary tumor, (b) Pituitary surgical damage, (c) Hypothalamic disease, (d) Pituitary irradiation, (e) Pituitary trauma, (f) Sheehan's syndrome, (g) Autoimmune hypophytis, (h) Hypophytis associated with an inflammatory condition, (i) Deficiency of 3 or more anterior pituitary hormones AND (2) Pt is receiving active supplementation of deficient hormones as necessary AND (3) (a) Pt has a low IGF-1 level and other causes of low IGF have been excluded OR (3) (b) Pt has failed standardized provocative testing as demonstrated by serum GH conc less than 5mcg/L when measured by RIA or less than 2.5mcg/L when measured by IRMA, ii. Adult dxed with childhood GHD (1) Retesting using the parameters in 2(i)(3)(b) indicates GHD persists OR (2) Pt is dxed with panhypopituitarism and IGF-I deficiencies exist as outlined in 2(i)(3)(c), b. Reauth: Continued efficacy both clinically and by lab testing. Ped GHD AND Adult GHD: Endocrinologist 1. Ped GHD: Initial: 6 mo, Reauth: 12 mo, 2. HIV wasting: 48 wks LIFETIME, 3. All others: 1. Chronic Renal Insufficiency: a. Meet ALL of the following: i. Pt dxed with CRI AND has not yet received renal transplant, ii. Existing metabolic disorders have been corrected, iii. Ht more than 2 SD below the population mean OR less than 3rd percentile, iv. Height velocity less than 4cm/yr or less than 10th percentile of normal for age and gender, 2. Turner Syndrome: a. Meet ALL of the following: 75
75 i. Dx of TS confirmed by blood karotype or fibroblast studies, ii. Ht of female pt plotted on TS-specific growth curve AND pt is less than 5th percentile of normal growth curve for girls, 3. Prader-Willi Syndrome: a. Meet ALL of the following: i. Dx of PWS confirmed by appropriate genetic testing, ii. Ht more than 2 SD below the pop mean OR less than 3rd percentile, iii. Ht velocity less than 3cm/yr or less than 10th percentile of normal for age and gender, 4. Small for Gestational Age: a. Meet ALL of the following: i. Dx of SGA as defined as one of the following: (1) Birth weight of less than 2,500g at gestational age of greater than 37 weeks, (2) OR birth weight or length less than 3rd percentile for gestational age, ii. Pt has failed to catch up in ht by 2 yo, 5. AIDS-Related Wasting: a. Meet ALL of the following: i. Involuntary weight loss of more than 10% pre-illness body weight or a BMI less than 20, ii. Failure to respond to dronabinol (Marinol) OR megesterol acetate (Megace), iii. Chronic diarrhea (defined as more than 3 loose stools/day for more than 30 days) OR Chronic weakness and documented fever (30 days, intermittent or constant) in the absence of concurrent illness or condition other than HIV infection that would otherwise explain the symptoms. 76
76 HALAVEN HALAVEN * Breast Cancer * Soft-Tissue Sarcoma 1. Previous failure of at least TWO chemotherapeutic regimens, 2. Previous treament includes an anthracycline AND a taxane Oncologist 77
77 HARVONI HARVONI * Hepatitis C Virus (HCV) and Hepatitis B Virus (HBV) Co-Infection * Hepatitis C Virus (HCV) and Human Immunodeficiency Virus (HIV) Co-Infection * Hepatitis C Virus (HCV), Genotype 1a * Hepatitis C Virus (HCV), Genotype 1b * Hepatitis C Virus (HCV), Genotype 3 * Hepatitis C Virus (HCV), Genotype 4 * Hepatitis C Virus (HCV), Genotype 5 * Hepatitis C Virus (HCV), Genotype 6 1. Chart notes showing genotype Gastroenterologist, Infectious Disease Specialist, or Transplant Specialist Maximum 24 weeks 78
78 HEPATITIS C PEGASYS, PEGASYS PROCLICK * Hepatitis B Virus (HBV) * Hepatitis C Virus (HCV) and Hepatitis B Virus (HBV) Co-Infection * Hepatitis C Virus (HCV) and Human Immunodeficiency Virus (HIV) Co-Infection * Hepatitis C Virus (HCV), Genotype 1a * Hepatitis C Virus (HCV), Genotype 1b * Hepatitis C Virus (HCV), Genotype 2 * Hepatitis C Virus (HCV), Genotype 3 * Hepatitis C Virus (HCV), Genotype 4 * Hepatitis C Virus (HCV), Genotype 5 * Hepatitis C Virus (HCV), Genotype 6 1. For Hep B dx: a. Pre-treatment HBV DNA levels are greater than 20,000 IU/ml, b. Must be used as monotherapy Gastroenterologist or Infectious Disease Initial: 24 Wks, 79
79 Reauth: 24 Wks 1. Pegylated interferon: For reauth: Must provide HCV viral load at 24 weeks 80
80 HETLIOZ HETLIOZ * Non-24 Hour Sleep-Wake Disorder Pt is totally blind without light perception Sleep specialist or Neurologist 81
81 HUMIRA HUMIRA, HUMIRA PEDIATRIC CROHNS D, HUMIRA PEN, HUMIRA PEN-CROHNS DISEASE, HUMIRA PEN-PSORIASIS STAR * Ankylosing Spondylitis * Juvenile Idiopathic Arthritis (JIA) * Plaque Psoriasis * Psoriatic Arthritis (PsA) * Rheumatoid Arthritis (RA) * Ulcerative Colitis (UC) 1. RA, JRA, PsA dx: a. Pt has failed at least three months therapy on at least ONE of the following: i. methotrexate, ii. leflunomide, iii. hydroxychloroquine, iv. sulfasalazine, v. injectable gold, vi. oral gold, vii. azathioprine, viii. penicillamine, ix. cyclosporine, 2. Hidradenitis suppurativa dx: a. Pt has lesions present in at least two distinct anatomical areas, one of which is Hurley Stage II or III Rheumatologist, Dermatologist, Gastroenterologist, or Ophthalmologist 82
82 IBRANCE IBRANCE * Breast Cancer 1. Ibrance used as initial therapy: a. Used in combination with letrozole, 2. Ibrance used after endocrine-based therapy: a. Used in combination with fulvestrant, b. If pt is pre- or perimenopausal: Ibrance and fulvestrant used in combianation with a luteinizing homrone-releasing hormone agonist Oncologist 83
83 ICLUSIG ICLUSIG * Acute Lymphocytic Leukemia (ALL) * Chronic Myelogenous Leukemia (CML) 1. CML dx: a. Pt's CML is in chronic phase, accelerated phase, or blast phase, 2. ALL dx: a. Pt has previous trial on Gleevec Oncologist or Hematologist 84
84 IDHIFA IDHIFA * Acute Myelogenous Leukemia (AML) 1. Cancer has an isocitrate dehydrogenase-2 (IDH2) mutation as detected by a FDA-approved test, 2.Pt has relapsed or is refractory to one or more prior anticancer regimens Oncologist or Hematologist BvsD Determination 85
85 ILARIS ILARIS * Juvenile Idiopathic Arthritis (JIA) Combination therapy with TNF antagonist 1. For all dx EXCEPT CAPS, TRAPS, HIDS/MKD, FMF or SJOA: Pt has had prior trial on BOTH of the following: a. Kineret, b. Actemra Rheumatologist, Dermatologist, or Immunologist 6 Months 86
86 IMBRUVICA IMBRUVICA * Chronic Lymphocytic Leukemia (CLL) * Mantle Cell Lymphoma (MCL) * Marginal Zone Lymphoma * Waldenstrom's Macroglobulinemia Pt has failed at least ONE prior therapy Oncologist or Hematologist 87
87 IMFINZI IMFINZI * Urothelial Carcinoma 1. Pt has an autoimmune disease that requires treatment with a corticosteroid or other systemic immunosuppressive treatment, 2. Pt has known active infection with HIV, tuberculosis, hepatitis B, hepatitis C, or a history of organ or allogeneic stem cell transplant 1. Pt has experienced disease progression following platinum-containing chemotherapy, 2. Pt has not previously received treatment with anti-pd-1, anti-pd-l1, or anti-ctla-4 therapy Oncologist 88
88 IMMUNOTHERAPY GRASTEK, ORALAIR, RAGWITEK * Allergic Rhinitis * Asthma Pt has severe, unstable, or uncontrolled asthma 1. Initial: a. Pt has experienced allergy symptoms due to grass-pollen induced allergic rhinitis, b. Pt has previous trial and failure of at least ONE intranasal corticosteroid AND at least ONE oral antihistamine, c. Pt will be started on the therapy in an appropriate timeframe before allergy season as follows: i. Started 12 weeks prior to the beginning of grass pollen season, ii. For Oralair: Started at least 16 weeks prior to the beginning of grass pollen season, 2. Reauth: a. Documentation of positive clinical response to therapy 1. For Grastek: Between 5 and 65, 2. For Ragwitek: Between 18 and 65, 3. For Oralair: Between 10 and 65 Allergist or Immunologist 10 Months 89
89 90
90 INCRELEX INCRELEX * Primary Insulin-Like Growth Hormone Factor (IGF-1) Deficiency 1. Height standard deviation score of less than -3 based on age and gender, 2. Basal IGF-1 standard deviation score of less than -3 based on age and gender, 3. Normal or elevated growth hormone levels, 4. Pt must have open epiphyses, 5. Gh stimulation test of greater than 10 mcg/l. 2 years old or older Endocrinologist or consult 91
91 INGREZZA INGREZZA * Tardive Dyskinesia Pt has previous trial on tetrabenazine Movement Disorder Specialist, Neurologist, or Psychiatrist 92
92 INLYTA INLYTA * Renal Cell Carcinoma (RCC) Pt has failed prior systemic therapy Oncologist 93
93 IRESSA IRESSA * Non-Small Cell Lung Cancer (NSCLC) 1. Pt has ONE of the following: a. EGFR exon 19 deletion, b. EGFR exon 21 deletion, 2. Iressa is used as first-line therapy Oncologist 94
94 ISTODAX ISTODAX (OVERFILL) * T-Cell Lymphoma Pt received at least ONE previous systemic therapy Oncologist 95
95 IVIG BIVIGAM, CARIMUNE NANOFILTERED, FLEBOGAMMA DIF, GAMASTAN S/D, GAMMAGARD LIQUID, GAMMAGARD S/D IGA LESS TH, GAMMAKED, GAMMAPLEX, GAMUNEX-C, OCTAGAM, PRIVIGEN * Antibody Deficiency with Normal Serum Immunoglobin Levels * Chronic Inflammatory Demylinating Polyneuropathy (CIDP) * Chronic Lymphocytic Leukemia (CLL) * Common Variable Immunodeficiency * Congenital Agammaglobulinemia * Dermatomyositis * Guillain-Barre Syndrome * Immune Mediated Blistering Disease (pemphigus/pemphigoid), Clincally Confirmed * Immune Mediated Thrombocytopenia * Kawaski Syndrome * Multiple Sclerosis (MS) * Polymyositis * Primary Immunodeficiency * Severe Combined Immunodeficiency * Specific (Qualitative) Antibody Deficiency Syndrome * Stevens-Johnson Syndrome * Stiff Person Syndrome * Toxic Epidermal Necrolysis * Wiskott-Aldrich Syndrome * X-Linked with Hyperimmunoglobulin M Immunodeficiency 1. For Kawasaki disease dx: a. IF pt after 10 days of illness: persistent fever without explanation OR aneurysms and ongoing systemic inflammation, 96
96 2. For HIV dx: a. CD4 count of less than 200 cells/ml, 3. For Thrombo dx: a. Platelet count less than 20,000, 4. For CLL dx: a. Hypogammaglobulinemia shown by less than 500 mg/dl, 5. For Transplant dx: a. Within 100 days of transplant OR hypogammaglobulinemia after 100 days, 6. For RRMS dx: a. Failure to at least TWO of the following: i. Betaseron, ii. Avonex, iii. Rebif, iv. Copaxone, v. Gilenya, 7. For Dermatomyositis dx: a. Failure to IV steroids AND failure to azathoprine OR methotrexate For Kawasaki disease dx: less than 18 years old BvsD determination 97
97 JADENU JADENU SPRINKLE * Iron Toxicity * Transfusional Iron Overload 1. For blood transfusion dx: a. Pt's serum ferritin is greater than 1000 mcg/l, b. Pt has failed subcutaneous deferoxamine through an inability to achieve desired goals of therapy or been intolerant to therapy, 2. For non-transfusion-dependent thalassemia dx: a. Pt's liver iron concentration is at least 5 mg Fe per gram of dry weight, b. Pt's serum ferritin is greater than 300 mcg/l, c. Pt has failed subcutaneous deferoxamine through an inability to achieve desired goals of therapy or been intolerant to therapy 1. For blood transfusion dx: 2 years old and older, 2. For non-transfusion-dependent thalassemia dx: 10 years old and older 98
98 JAKAFI JAKAFI * Myelofibrosis * Polycythemia Vera (PV) * Post-Polycythemia Vera Myelofibrosis * Thrombocythemia Myelofibrosis 1. Pt has enlarged spleen shown by MRI or CT, 2. Platelet count greater than or equal to 50X10(9)/L Oncologist or Hematologist 99
99 JEVTANA JEVTANA * Prostate Cancer 1. Previous treatment with docetaxel-containing regimen, 2. Combination therapy with prednisone Oncologist or Urologist 100
100 KADCYLA KADCYLA * Breast Cancer Combination therapy 1. Pt has previously received BOTH of the following: a. Taxane therapy, b. Herceptin Oncologist BvsD determination 101
101 KALYDECO KALYDECO * Cystic Fibrosis 1. Pt genotyped by an FDA-cleared CF mutation test, 2. Pt have one mutation in the CFTR gene that is responsive to ivacaftor potentiation based on clinical and/or in vitro assay data Tablet: 6 years old or older, Granules: 2 years old to 5 years old Pulmonologist 102
102 KEPIVANCE KEPIVANCE * Acute Lymphocytic Leukemia (ALL) * Acute Myelogenous Leukemia (AML) * Chronic Lymphocytic Leukemia (CLL) * Essential Thrombocythemia (ET) * Hodgkin's Disease * Mucositis Prophylaxis * Non-Hodgkin's Lymphoma (NHL) * Polycythemia Vera (PV) 1. Pt will be undergoing a bone marrow transplant, 2. Pt will be undergoing total-body irradiation, 3. Pt's chemotherapy regimen consists of at least ONE medication that is predicted to result in greater than WHO Grade 3 mucositis, 4. Pt will NOT be receiving a high dose of melphalan preparative regimen Hematologist or Oncologist 103
103 BvsD determination 104
104 KEVZARA KEVZARA * Rheumatoid Arthritis (RA) 1. Pt has persistent active disease and been treated for at least 3 months on at least ONE of the following: a. Methotrexate, b. Leflunomide, c. Hydroxychloroquine, d. Sulfasalazine, e. Injectable gold salts, f. Azathioprine, g. D-penicillamine, h. Cyclosporine, 2. Pt has previous trial on Enbrel OR Humira 18 yo or older Rheumatologist or consult 105
105 KEYTRUDA KEYTRUDA * Head and Neck Cancer * Malignant Melanoma * Non-Small Cell Lung Cancer (NSCLC) 1. Autoimmune disease, 2. Current immunosuppression, 3. Previous use of Opdivo 1. For Melanoma dx: a. If previous trial on Yervoy, pt did NOT experience an immune-mediated adverse reaction to Yervoy requiring use of corticosteroids, 2. NSCLC dx: a. Tumor expresses PD-L 1, b. If pt has an EGFR or ALK genomic tumor aberration, pt has had disease progression on FDA-approved therapy for these aberrations, c. Pt has experienced progression on prior platinum-based chemotherapy, 3. Head and Neck cancer dx: a. Pt has experienced disease-progression on prior platinum-based chemotherapy Oncologist or Hematologist 106
106 BvsD determination 107
107 KINERET KINERET * Juvenile Idiopathic Arthritis (JIA) * Neonatal-Onset Multisystem Inflammatory Disease (NOMID) * Rheumatoid Arthritis (RA) 1. Pt has previous trial on at least ONE of the following: a. Enbrel, b. Humira, 2. Pt has previous trial on at least ONE of the following: a. Actemra, b. Cimzia, c. Cosentyx, d. Entyvio, e. Orencia, f. Otezla 108
108 KISQALI KISQALI, KISQALI FEMARA 200 DOSE, KISQALI FEMARA 400 DOSE, KISQALI FEMARA 600 DOSE * Breast Cancer 1. Pt will receive an aromatase inhibitor in combination with Kisqali as initial endocrine based therapy for advanced or metastatic disease, 2. Pt is postmenopausal, 3. Pt has previous trial on letrozole Oncologist 109
109 KORLYM KORLYM * Cushing's Syndrome Pt using long-term corticosteroid 1. Pt has previously failed surgery or chemotherapy to correct Cushing's disease OR is ineligible for surgery, 2. Pt with type II diabetes diagnosis, 3. HgA1c is 8.0% or greater, 4. Pt has treatment failure with at least TWO of the following: a. Insulin, b. metformin, c. meglitinides, d. sulfonylureas, e. thiazolidinediones, f. DPP4 inhibitors, g. GLP-1 agonists, 5. If pt is female: a. Pt has negative pregnancy test within past 14 days, b. Pt is currently using non-hormonal form of birth control Endocrinologist Initial: 6 months, Reauth: 110
110 KYPROLIS KYPROLIS * Multiple Myeloma 1. Pt has received at least ONE prior therapy, 2. Disease has progressed within 60 days of completion of the last therapy Hematologist or Oncologist 111
111 LARTRUVO LARTRUVO * Soft-Tissue Sarcoma 1. Pt has known ejection fraction less than 50%, 2. Pt has experienced any of the following in the past 6 months: a. Unstable angina pectoris, b. Myocardial infarction 1. Pt is not a candidate for curative treatment with radiotherapy or surgery, 2. Lartruvo will be used in combination with doxorubicin on day 1 of each 21-day cycle for the first 8 cycles of therapy, 3. An anthracycline-containing regimen is appropriate for the pt's treatment, 4. Pt has an ECOG performance score of 2 or less Oncologist 6 Months 112
112 LENVIMA LENVIMA 10 MG DAILY DOSE, LENVIMA 14 MG DAILY DOSE, LENVIMA 18 MG DAILY DOSE, LENVIMA 20 MG DAILY DOSE, LENVIMA 24 MG DAILY DOSE, LENVIMA 8 MG DAILY DOSE * Renal Cell Carcinoma (RCC) * Thyroid Cancer 1. Renal cell carcinoma dx: a. Pt has previously been treated with anti-angiogenic therapy, b. Will be used in combination with everolimus, 2. Thyroid cancer dx: a. Tumor is refractory to treatment with radioactive iodine, b. Used as monotherapy 113
113 LIDODERM LIDOCAINE * Post-Herpetic Neuralgia 114
114 LONSURF LONSURF * Colorectal Cancer 1. Pt has previous therapy on the following: a. A fluoropyrimidine, b. Oxaliplatin, c. Irinotecan, d. Bevacizumab, 2. If cancer is KRAS wild type, pt has received previous therapy with anti-egfr therapy Oncologist 115
115 LYNPARZA LYNPARZA * Ovarian Cancer Combination therapy Pt has previous trial on at least THREE prior lines of chemotherapy Oncologist 116
116 MAVYRET MAVYRET * Hepatitis C Virus (HCV) Confirmation of genotype Gastroenterologist, Infectious Disease Specialist, or Transplant Specialist 16 Weeks 117
117 MEKINIST MEKINIST * Malignant Melanoma Previous use of Tafinlar, Mekinist, Keytruda, or Opdivo 1. Pt is BRAF(V600E or V600K) mutation positive, 2. Monotherapy or in combination with Tafinlar Oncologist, Hematolgist, or Dermatologist 118
118 MIGRANAL DIHYDROERGOTAMINE MESYLAT * Migraine Headaches with or without Aura 1. Pt experiences at least 2 migraines per month, 2. Pt has trial or contraindication to at least TWO of the following: a. Sumatriptan, b. Rizatriptan, c. Zolmitriptan, d. Naratriptan 18 years old or older Neurologist 119
119 MODAFANIL MODAFINIL * Narcolepsy * Obstructive Sleep Apnea/Hypopnea Syndrome (OSAHS) * Shift Work Sleep Disorder (SWSD) 120
120 MS AUBAGIO, AVONEX, AVONEX PEN, COPAXONE, EXTAVIA, GILENYA, PLEGRIDY, PLEGRIDY STARTER PACK, TECFIDERA, TECFIDERA STARTER PACK * Multiple Sclerosis (MS) Neurologist 121
121 MYALEPT MYALEPT * Diabetes Mellitus 1. Pt has baseline leptin levels of less than 8 ng/ml for males OR less than 12 ng/ml for females, 2. Pt has ONE of the following: a. Diagnosis of diabetes and is being treated with Metformin AND at least one other antidiabetic agent, b. Diagnosis of hypertriglyceridemia and is being treated with at least ONE antihyperlipidemic agent, 3. Reauth: a. Pt has been screened for the presence of anti-metreleptin antibodies, b. If presence of anti-metreleptin antibodies, pt must still be receiving benefit from Myalept therapy, c. Pt shows improvement in hemoglobin A1c OR fasting triglyceride level Endocrinologist Initial: 6 months, Reauth: 122
122 MYLOTARG MYLOTARG * Acute Myelogenous Leukemia (AML) Cancer is CD33-positive Oncologist or Hematologist 123
123 NAFCILLIN NAFCILLIN SODIUM * Bacterial Meningitis * Endocarditis * Staphylococcal Infectious Disease caused by Penicillinase-Producing Staphylococci Species BvsD determination 124
124 NATPARA NATPARA * Hypoparathyroidism 1. Pt's Ionized Ca2+ is greater than 1.10 mmol/l, 2. Pt is symptomatic with presence of at least ONE of the following: a. tetany, b. carpopedal spasm, c. seizures, d. hypotension, e. prolongation of QT interval, 3. Pt's vitamin D level is greater than 30 ng/ml Endocrinologist 125
125 NERLYNX NERLYNX * Breast Cancer 1. Treatment for longer than 1 year 1. Pt has had treatment with trastuzumab within the past 2 years Oncologist 126
126 NEXAVAR NEXAVAR * Hepatocellular Carcinoma (HCC) * Renal Cell Carcinoma (RCC) 1. Used as monotherapy, 2. For HCC dx: a. Treatment for unresectable tumor or recurrent disease 127
127 NINLARO NINLARO * Multiple Myeloma 1. Pt is refractory to lenalidomide or proteasome inhibitor therapy 1. Ninlaro will be used in combination with Revlimid and dexamethasone, 2. Pt has previous trial on at least ONE other therapy Oncologist or Hematologist BvsD Determination 128
128 NORTHERA NORTHERA * Neurogenic Orthostatic Hypotension 1. Pt has previous trial on BOTH of the following: a. Midorine, b. Fludrocortisone Cardiologist or Neruologist 2 Weeks 129
129 NOXAFIL NOXAFIL * Aspergillosis Prophylaxis * Oropharyngeal Candidiasis (Thrush) 1. For aspergillus or candida prophylaxis: a. Pt is at high risk of developing infections secondary to being severely immunocompromised, 2. For oropharyngeal candidiasis: a. Pt has previous failure on BOTH of the following: 1) Itraconazole, 2) Fluconazole 1. For apergillus or candida prophylaxis: 13 years old or older 6 Months 130
130 NUEDEXTA NUEDEXTA * Pseudobulbar Affect (PBA) 1. Pt has score of 13 or greater on Center for Neurologic Study-Liability Scale (CNS-LS) for pseudobulbar affect (PBA) Neurologist 6 Months 131
131 NULOJIX NULOJIX * Kidney Transplant Rejection Prophylaxis 1. Pt has (or soon will have) a kidney transplant, 2. Taken in combination with basiliximab induction, mycophenolate mofetil, and corticosteroids, 3. Pt is EBV seropositive 18 years old or older 132
132 NUPLAZID NUPLAZID * Parkinson's Disease Psychosis with Hallucinations/Delusions 1. Initial: a. Onset of psychosis took place after the diagnosis of Parkinson's disease, b. Pt has previous trial on treatment with clozapine or quetiapine, 2. Reauth: a. Pt experienced a decrease in psychosis related symptoms while on treatment Neurologist or Psychiatrist Initial: 3 months, Reauth: 12 months 133
133 NUVIGIL ARMODAFINIL * Narcolepsy * Obstructive Sleep Apnea/Hypopnea Syndrome (OSAHS) * Shift Work Sleep Disorder (SWSD) 134
134 OCALIVA OCALIVA * Primary Biliary Cholangitis (PBC) 1. Pt does not have clinically significant complications of PBC 1. Initial: a. Dx of PBC is confirmed by at least TWO of the following: i. Elevated mean alkaline phosphatase (ALP) levels of at least 1.5 times the upper limit of normal (ULN) from at least two consecutive readings separated by at least one month (more than 175 U/L for women and 195 U/L for men), ii. Positive for antimitochondrial antibody (AMA) titer (greater than 1:40 titer on immunofluorescence or M2 positive by enzyme-linked imunoabsorbant assay) or PBC-specific antinuclear antibodies, iii. Liver biopsy showing histological evidence of PBC (nonsuppurative destructive cholangitis and destruction of interlobular bile ducts), b. Pt has trial on ursodiol, c. Ocaliva will be taken in combination with ursodiol, d. Pt has ALP at least 1.67 times the upper limit of normal (ULN) (At least 197 U/L for females and 207 U/L for males), e. Pt has a total bilirubin greater than the ULN, but less than 2 times the ULN (value between mg/dl for females and mg/dl for males), 2. Reauth: a. Pt has acheived an ALP less than 1.67 times the ULN, b. Pt had an ALP decrease of at least 15% compared to baseline, c. Pt's current total bilirubin is within normal limits Gastroenterologist or Transplant Specialist 135
135 136
136 OCTREOTIDE OCTREOTIDE ACETATE * Acromegaly * Carcinoid * Gastroenteropancreatic Neuroendocrine Tumor * Vasoactive Intestinal Peptide Secreting Tumors (VIPomas) 1. For acromegaly: a. Has patient failed at least TWO of the following: i. Surgical resection, ii. Pituitary irradiation, iii. Bromocriptine, b. Pt has elevated levels of growth hormone and IGF-1, 2. For carcinoid: a. Pt is suffering from severe diarrhea and flushing episodes associated with disease, 3. For VIPoma: a. Pt has profuse water diarrhea associated with disease Endocrinologist, Oncologist, or Gastroenterologist 1. For acromegaly: 6 mo, 137
137 2. For others: Plan year BvsD determination 138
138 OLYSIO * Hepatitis C Virus (HCV) and Hepatitis B Virus (HBV) Co-Infection * Hepatitis C Virus (HCV) and Human Immunodeficiency Virus (HIV) Co-Infection * Hepatitis C Virus (HCV), Genotype 1a * Hepatitis C Virus (HCV), Genotype 1b 1. Previous treatment with a protease inhibitor, 2. Genotype 1a: Screening revealed presence of the NS3 Q80K polymorphism 1. Used in combination with pegylated interferon-alfa and ribavirin OR 2. Used in combination with Sovaldi Gastroenterolgist, Infectious Disease Specialist, or Transplant Specialist Up to 24 Weeks 139
139 ONCOLOGICS ABRAXANE, LEVOLEUCOVORIN * Breast Cancer * Non-Small Cell Lung Cancer (NSCLC) * Pancreatic Cancer 140
140 ONFI ONFI * Lennox-Gastaut Syndrome 1. Pt has previous trail on at least TWO AED medications Neurologist OR For non-lennox-gastaut indications: Epileptologist 141
141 OPDIVO OPDIVO * Head and Neck Cancer * Hodgkin's Lymphoma * Malignant Melanoma * Renal Cell Carcinoma (RCC) * Squamous Non-Small Cell Lung Cancer (NSCLC) 1. Autoimmune disease, 2. Current immunosuppression, 3. Previous use of Opdivo 1. Melanoma dx: a. If pt has previous trial on Yervoy, pt did NOT experience an immune-mediated adverse reaction to Yervoy requiring use of corticosteroids, b. Pt is NOT positive for BRAF V600E or V600K mutation OR c. Pt is BRAF V600E or V600K mutation positive AND has previously tried at least ONE of the following: i. Mekinist, ii. Tafinlar, iii. Zelboraf, 2. NSCLC dx: a. Pt experienced disease-progression on prior therapy with platinum-based chemotherapy, 3. RCC dx: a. Pt has experienced progression with prior anti-angiogenic therapy, b. Pt has a Karnofsky Performance Score of 70 percent or greater (ECOG greater than or equal to 2), c. Pt has not been previously treated with a mtor inhibitor, d. Pt does not have a hx of or concurrent brain metastases, 4. Hodgkin's Lymphoma dx: a. Pt has experienced progression after an autologous hematopoietic stem cell transplant, b. Pt has previously received post-transplantation brentuximab vedotin, c. Pt ECOG score is less than 2, 142
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